Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)

Cancer. Clinical Trial

Official title:

Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01584115
• Other study ID #: 6889
• Secondary ID: CNPq 577582/2008
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 21, 2012
• Last updated: April 24, 2012
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2012
• Source: Instituto de Investigação em Imunologia
• Contact: Pedro Giavina-Bianchi, PhD,MD
• Phone: (5511) 26616098
• Email: pbianchi[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.

Description:

The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.

Exclusion Criteria:

• Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer.
• Lung Cancer.
• Melanoma.
• Ovarian Cancer.
• Ovarian Neoplasms

Intervention

Biological:
• NY-ESO-1 combined with MPLA
Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).
• NY-ESO-1 combined with MPLA vaccine
Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da FMUSP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigação em Imunologia	Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	CTCAE (Common Terminology Criteria for Adverse Events)	Six months after immunization.	Yes
Secondary	Immunogenicity	IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).	Six months after immunization.	No